Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

Study of Vaccine Formulations for RSV and Flu H5 in Adults Aged 18-49

Recruiting
18 years - 49 years
All
Phase 1
570 participants needed
6 Locations

Study Overview

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years.

The total duration of study participation for each participant varies by stage and treatment arm.

Stage 1:

  • For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant.
  • For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant.

Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus (RSV), Influenza A(H5N1)
  • Age: 18 years - 49 years
  • Gender: All

Inclusion Criteria:

  • Aged 18 to 49 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
  • Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
  • Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration.

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates the safety and immune response of different vaccine formulations for RSV and Flu H5 in healthy adults aged 18 to 49 years.

The study focuses on assessing how safe the vaccines are and how well they trigger an immune response. It looks at different formulations to see how the body reacts.

  • Who can participate: Participants must be aged 18 to 49 years. Women must not be pregnant or breastfeeding and must use effective contraception if of child-bearing potential.
  • Study details: Participants will receive different vaccine formulations to evaluate safety and immune response. Some may receive a placebo, an inactive substance that looks like the investigational vaccine but does not contain any medicine.
  • Study timelines: The study will last approximately 7 months for Stage 1 (Arms 1, 2, 3) and Stage 2, and 6 months for Stage 1 (Arms 4, 5, 6).
Updated on 05 May 2026. Study ID: NCT07516418

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